Neuromuscular BlockadeNCT04762420
Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring
An observational study of Neuromuscular Blockade and Anesthesia, run by Hospital do Divino Espírito Santo de Ponta Delgada at 1 site in Portugal.
Trial summary
Many clinicians continue to rely on subjective evaluation in making decisions about the adequacy of neuromuscular function before tracheal extubation rather than using quantitative monitoring. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blockade, Anesthesia, TOF
- What is being tested?
- Dose of sugammadex according to SSD and QSD
- How many people
- 66 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2019to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population was made of 66 individuals, aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) neuromuscular blockade and subsequent reversal with sugammadex.
Who may be able to join
- Patients aged 18-75 years;
- Above patients who underwent general anesthesia with rocuronium neuromuscular blockade and subsequent reversal with sugammadex.
Who cannot join
- American Society of Anesthesiologists physical status V;
- Emergency surgery;
- Hypersensitivity history to rocuronium or sugammadex;
- Severe renal impairment/dialysis;
- Neuromuscular diseases;
- Severe hepatic disease;
- Pre-existing coagulopathies;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Many clinicians continue to rely on subjective evaluation in making decisions about the adequacy of neuromuscular function before tracheal extubation rather than using quantitative monitoring. The aim was to compare the sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience versus the dose determined by quantitative monitoring (QSD) to determine if the subjective dose was appropriate.
Read the detailed description
Materials and Methods:
After obtaining approval from the Institute Ethics Committee, a prospective 3-month study in patients aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) NMB and subsequent reversal with sugammadex, was carried out. American Society of Anesthesiologists (ASA ) physical status V, emergency surgery, patients with hypersensitivity history to rocuronium or sugammadex, severe renal impairment/dialysis, neuromuscular diseases, severe hepatic disease, pre-existing coagulopathies and pregnancy were excluded. Monitoring included ASA standard monitoring, bispectral index and NMB monitoring using TOFscan® monitor. The senior anaesthesiologist was blinded to the TOFscan®, which was only available to the author.
At the time of pharmacologic reversal of NMB, both the sugammadex dose proposed by the anaesthesiologist (SSD) and the dose suggested by TOFscan® (QSD) according to the Portuguese recommendations for the management of NMB were recorded. Afterwards the QSD was administered to overcome ethical issues. When train-of-four (TOF) count was 0, the author performed the post tetanic count (PTC) stimulus to determine the recommended dose. The SSD was considered appropriate if it was within 10% of the QSD for the depth of NMB. All patients were extubated with a TOF ratio > 0.9 (TOFr) and both the rocuronium and sugammadex dose were calculated based on the real patient weight. Data regarding anaesthesia, duration of anaesthesia and dosing pattern of rocuronium were also noted. The results were analysed descriptively.
- Being tested
- Dose of sugammadex according to SSD and QSD
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose of sugammadex according to SSD and QSDOther
At the time of pharmacologic reversal of the NMB, both the SSD and QSD, according to portuguese guidelines on the management of the NMB, were recorded. The QSD was then administered to the patient. The SSD was considered appropriate if it was within 10% of the recommended dose for the given depth of NMB, as measured by TOFscan® monitor. The results were analyzed descriptively.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience. | Not described Receives: Other: Dose of sugammadex according to SSD and QSD | |
| Dose of Sugammadex determined by quantitative monitoring (QSD). | Not described Receives: Other: Dose of sugammadex according to SSD and QSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex.
Given the interindividual variability response to neuromuscular block, which makes it difficult to subjectively determine the dose needed, the aim was to compare the sugammadex dose as suggested by senior anaesthesiologists based on clinical experience versus the dose determined by quantitative monitoring to determine if the subjective dose was appropriate.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Feb 2019
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Divino Espírito Santo de Ponta Delgada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto Ruivo, Hospital do Divino Espírito Santo de Ponta Delgada
- Investigators
- Paulo Frias, MD, Principal investigator, Hospital do Divino Espírito Santo de Ponta Delgada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762420
- Sponsor's protocol ID
- DivinoEspíritoSanto
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prospective, 3-month study in 66 patients aged 18-75 years who underwent general anesthesia with rocuronium neuromuscular block and reversal with sugammadex.
Publications
Esteves S, Roxo A, Resendes H, Pereira L, Fernandes N, Borges S. Recomendações Portuguesas para a Gestão do Bloqueio Neuromuscular 2017. Rev Soc Port Anestesiol. 2018; 27: 4-52.
Dutu M, Ivascu R, Tudorache O, Morlova D, Stanca A, Negoita S, Corneci D. Neuromuscular monitoring: an update. Rom J Anaesth Intensive Care. 2018 Apr;25(1):55-60. doi: 10.21454/rjaic.7518.251.nrm.
PubMed 29756064Unterbuchner C. Neuromuscular Block and Blocking Agents in 2018. Turk J Anaesthesiol Reanim. 2018 Apr;46(2):75-80. doi: 10.5152/TJAR.2018.200318. Epub 2018 Apr 1. No abstract available.
PubMed 29744239Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.
PubMed 28044330Cammu G. Sugammadex: Appropriate Use in the Context of Budgetary Constraints. Curr Anesthesiol Rep. 2018;8(2):178-185. doi: 10.1007/s40140-018-0265-6. Epub 2018 Mar 20.
PubMed 29904285Ciara Mitchell, Steve Lobaz. An Overview of Sugammadex. ATOTW 332 (2016); 1-6
Daniel Moi. Residual Neuromuscular Blockade, ATOTW 290 (2013); 1-8
A. Castagnoli, M. Adversi, G. Innocenti, G.F. Di Nino and R.M. Melotti. Post-Operative Residual Curarization (PORC): A Big Issue for Patients' Safety. Risk Management for the Future - Theory and Cases, 2012, 117-136
Wycherley AS, Bembridge JL. Monitoring techniques; neuromuscular blockade and depth of anaesthesia. Anaesthesia and intensive care medicine (2017).
Syed F, Trifa M, Uffman JC, Tumin D, Tobias JD. Monitoring of Sugammadex Dosing at a Large Tertiary Care Pediatric Hospital. Pediatr Qual Saf. 2018 Oct 9;3(5):e113. doi: 10.1097/pq9.0000000000000113. eCollection 2018 Sep-Oct.
PubMed 30584640Takazawa T, Katsuyuki M, Sawa T, et al. The current status of sugammadex usage and the occurrence of sugammadex-induced anaphylaxis in Japan. APSF Newsletter 2018;33:1.
Goltz K, Dambach M, Schlapfer M, Biro P. Non-Feasibility to Estimate the Need for Reversal of Neuromuscular Relaxation from the Applied Rocuronium Dosing Pattern: A Retrospective Analysis of Anaesthesia Records. Turk J Anaesthesiol Reanim. 2018 Feb;46(1):57-61. doi: 10.5152/TJAR.2018.98705. Epub 2018 Feb 1.
PubMed 30140502de Boer HD, Carlos RV, Brull SJ. Is lower-dose sugammadex a cost-saving strategy for reversal of deep neuromuscular block? Facts and fiction. BMC Anesthesiol. 2018 Nov 6;18(1):159. doi: 10.1186/s12871-018-0605-6.
PubMed 30400850
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring
- ClinicalTrials.gov ID
- NCT04762420
- Acronym / sponsor ID
- DivinoEspíritoSanto
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital do Divino Espírito Santo de Ponta DelgadaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many clinicians continue to rely on subjective evaluation in making decisions about the adequacy of neuromuscular function before tracheal extubation rather than using quantitative monitoring. The aim was to compare the sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience versus the dose determined by quantitative monitoring (QSD) to determine if the subjective dose was appropriate.
Detailed description
Materials and Methods:
After obtaining approval from the Institute Ethics Committee, a prospective 3-month study in patients aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) NMB and subsequent reversal with sugammadex, was carried out. American Society of Anesthesiologists (ASA ) physical status V, emergency surgery, patients with hypersensitivity history to rocuronium or sugammadex, severe renal impairment/dialysis, neuromuscular diseases, severe hepatic disease, pre-existing coagulopathies and pregnancy were excluded. Monitoring included ASA standard monitoring, bispectral index and NMB monitoring using TOFscan® monitor. The senior anaesthesiologist was blinded to the TOFscan®, which was only available to the author.
At the time of pharmacologic reversal of NMB, both the sugammadex dose proposed by the anaesthesiologist (SSD) and the dose suggested by TOFscan® (QSD) according to the Portuguese recommendations for the management of NMB were recorded. Afterwards the QSD was administered to overcome ethical issues. When train-of-four (TOF) count was 0, the author performed the post tetanic count (PTC) stimulus to determine the recommended dose. The SSD was considered appropriate if it was within 10% of the QSD for the depth of NMB. All patients were extubated with a TOF ratio > 0.9 (TOFr) and both the rocuronium and sugammadex dose were calculated based on the real patient weight. Data regarding anaesthesia, duration of anaesthesia and dosing pattern of rocuronium were also noted. The results were analysed descriptively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience. | – | Other: Dose of sugammadex according to SSD and QSD |
| Dose of Sugammadex determined by quantitative monitoring (QSD). | – | Other: Dose of sugammadex according to SSD and QSD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population was made of 66 individuals, aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) neuromuscular blockade and subsequent reversal with sugammadex.
Key inclusion criteria (2 listed)
- Patients aged 18-75 years;
- Above patients who underwent general anesthesia with rocuronium neuromuscular blockade and subsequent reversal with sugammadex.
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists physical status V;
- Emergency surgery;
- Hypersensitivity history to rocuronium or sugammadex;
- Severe renal impairment/dialysis;
- Neuromuscular diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose of sugammadex according to SSD and QSDAt the time of pharmacologic reversal of the NMB, both the SSD and QSD, according to portuguese guidelines on the management of the NMB, were recorded. The QSD was then administered to the patient. The SSD was considered appropriate if it was within 10% of the recommended dose for the given depth of NMB, as measured by TOFscan® monitor. The results were analyzed descriptively. | Other | Dose of Sugammadex determined by quantitative monitoring (QSD)., Sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience. |
Primary outcome
The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex.
Time frame: 3 months
Given the interindividual variability response to neuromuscular block, which makes it difficult to subjectively determine the dose needed, the aim was to compare the sugammadex dose as suggested by senior anaesthesiologists based on clinical experience versus the dose determined by quantitative monitoring to determine if the subjective dose was appropriate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Results publicationEsteves S, Roxo A, Resendes H, Pereira L, Fernandes N, Borges S. Recomendações Portuguesas para a Gestão do Bloqueio Neuromuscular 2017. Rev Soc Port Anestesiol. 2018; 27: 4-52.
- Results publication: PubMed 29756064Dutu M, Ivascu R, Tudorache O, Morlova D, Stanca A, Negoita S, Corneci D. Neuromuscular monitoring: an update. Rom J Anaesth Intensive Care. 2018 Apr;25(1):55-60. doi: 10.21454/rjaic.7518.251.nrm.
- Results publication: PubMed 29744239Unterbuchner C. Neuromuscular Block and Blocking Agents in 2018. Turk J Anaesthesiol Reanim. 2018 Apr;46(2):75-80. doi: 10.5152/TJAR.2018.200318. Epub 2018 Apr 1. No abstract available.
- Results publication: PubMed 28044330Naguib M, Brull SJ, Johnson KB. Conceptual and technical insights into the basis of neuromuscular monitoring. Anaesthesia. 2017 Jan;72 Suppl 1:16-37. doi: 10.1111/anae.13738.
- Results publication: PubMed 29904285Cammu G. Sugammadex: Appropriate Use in the Context of Budgetary Constraints. Curr Anesthesiol Rep. 2018;8(2):178-185. doi: 10.1007/s40140-018-0265-6. Epub 2018 Mar 20.
- Results publicationCiara Mitchell, Steve Lobaz. An Overview of Sugammadex. ATOTW 332 (2016); 1-6
- Results publicationDaniel Moi. Residual Neuromuscular Blockade, ATOTW 290 (2013); 1-8
- Results publicationA. Castagnoli, M. Adversi, G. Innocenti, G.F. Di Nino and R.M. Melotti. Post-Operative Residual Curarization (PORC): A Big Issue for Patients' Safety. Risk Management for the Future - Theory and Cases, 2012, 117-136
- Results publicationWycherley AS, Bembridge JL. Monitoring techniques; neuromuscular blockade and depth of anaesthesia. Anaesthesia and intensive care medicine (2017).
- Results publication: PubMed 30584640Syed F, Trifa M, Uffman JC, Tumin D, Tobias JD. Monitoring of Sugammadex Dosing at a Large Tertiary Care Pediatric Hospital. Pediatr Qual Saf. 2018 Oct 9;3(5):e113. doi: 10.1097/pq9.0000000000000113. eCollection 2018 Sep-Oct.
- Results publicationTakazawa T, Katsuyuki M, Sawa T, et al. The current status of sugammadex usage and the occurrence of sugammadex-induced anaphylaxis in Japan. APSF Newsletter 2018;33:1.
- Results publication: PubMed 30140502Goltz K, Dambach M, Schlapfer M, Biro P. Non-Feasibility to Estimate the Need for Reversal of Neuromuscular Relaxation from the Applied Rocuronium Dosing Pattern: A Retrospective Analysis of Anaesthesia Records. Turk J Anaesthesiol Reanim. 2018 Feb;46(1):57-61. doi: 10.5152/TJAR.2018.98705. Epub 2018 Feb 1.
- Individual participant dataSharing planned: No. Prospective, 3-month study in 66 patients aged 18-75 years who underwent general anesthesia with rocuronium neuromuscular block and reversal with sugammadex.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Frias, MD principal investigator
Hospital do Divino Espírito Santo de Ponta Delgada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade and Anesthesia, run by Hospital do Divino Espírito Santo de Ponta Delgada at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04762420, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.